ILUVIEN® Implant for Diabetic Macular Edema
(NEW DAY Trial)
Trial Summary
What is the purpose of this trial?
This is a randomized, masked, active-controlled, parallel-group, multi-center study that will assess the efficacy of ILUVIEN as a baseline therapy in the treatment of Center Involving DME (CI-DME). The study will enroll patients who are either treatment naïve or have not received any DME treatments for the preceding 12 months as documented in medical records. Patients who received DME treatment \>12 months before screening, must not have received \>4 intravitreal injections. The study will compare 2 treatment regimens: ILUVIEN intravitreal implant (0.19 mg) followed by supplemental aflibercept as needed per protocol criteria (2 mg/0.05 mL), compared to intravitreal aflibercept loading dose (2 mg administered by intravitreal injection every 4 weeks for 5 consecutive doses) followed by supplemental aflibercept as needed per protocol criteria (2 mg/0.05 mL).
Research Team
Samer Kaba, MD
Principal Investigator
Alimera Sciences, Inc.
Eligibility Criteria
This trial is for adults over 18 with early Diabetic Macular Edema (DME) confirmed by SD-OCT and specific vision acuity scores. It's not for those with advanced diabetic eye disease, other causes of macular edema, recent certain eye treatments, or uncontrolled glaucoma.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either ILUVIEN intravitreal implant followed by supplemental aflibercept as needed, or intravitreal aflibercept loading dose followed by supplemental aflibercept as needed
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Aflibercept
- Iluvien 0.19 MG Drug Implant
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alimera Sciences
Lead Sponsor